Clinical Investigation to Assess the Efficacy of Manual Toothbrushes in the Reduction of Plaque and Gingivitis.

NCT06565897 | Completed Phase 2 FDA Drug

• 1 other identifier: CRO-2024-04-MTB-FL-DR
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Qualified subjects will be enrolled and randomized to one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after 1, 3, and 6, weeks of unsupervised product use at home. All subjects will be followed for adverse events throughout the study

Conditions

Plaque, Dental; Gingivitis

Outcome Measures

Primary Outcomes (2)

• Plaque assessment

  The dentition will be disclosed with disclosing solution and plaque scored according to the Refined Navy Plaque Index. Refinement of the Navy plaque index to increase plaque scoring efficiency in gum line and interproximal tooth areas.

  Initial reading, reading taken immediately following first brushing, 1-week, 3-weeks, and 6-weeks

• Gingivitis Assessment

  A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror.

  Initial reading, 1-week, 3-weeks, and 6-weeks

Study Arms (2)

Test regimen

EXPERIMENTAL

Brush with full ribbon toothpaste, 2x day / 2mins with paste \& toothbrush provided

Drug: Test regimen

Control regimen

ACTIVE COMPARATOR

Brush with full ribbon toothpaste, 2x day / 2mins with paste \& toothbrush provided

Drug: Control regimen

Interventions

Test regimen DRUG

toothpaste \& manual toothbrush

Test regimen

Control regimen DRUG

toothpaste \& manual toothbrush

Control regimen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form.
• Male and female subjects aged 18-70 years, inclusive.
• Availability for the six-week duration of the clinical research study.
• Good general health based on the opinion of the study investigator
• Minimum of 20 permanent natural teeth (excluding third molars).
• Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
• Initial mean plaque index of at least 0.6 as determined by Navy Plaque index.

You may not qualify if:

• Presence of orthodontic appliances.
• Presence of partial removable dentures.
• Tumor(s) of the soft or hard tissues of the oral cavity.
• Five or more carious lesions requiring immediate restorative treatment.
• Antibiotic use any time during the one-month period prior to entry into the study.
• Participation in any other clinical study or test panel within the one month prior to entry into the study.
• Dental prophylaxis during the past two weeks prior to baseline examinations.
• History of allergies to oral care/personal care consumer products or their ingredients.
• On any prescription medicines that might interfere with the study outcome.
• An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours.
• History of alcohol and/or drug abuse.
• Self-reported pregnancy and/or lactating subjects.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Consumer Research Consulting, LLC

Melbourne, Florida, 32940, United States

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• John Gallob, DMD

  Consumer Research Consulting, LLC.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 22, 2024
• Study Start: July 26, 2024
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: March 18, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)